Production Lab Tech 3

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The Manufacturing team at our Spruce site, supports production of antibody products for use in in vitro diagnostic (/VD) immunohistochemistry (IHC). All Production Lab Techs are expected to effectively perform the job functions defined in the "Essential Functions" and possess the skills and abilities in the "Knowledge, Skills, & Abilities sections below.

Level III Production Lab Tech are expected to be highly proficient in at least three of the work areas outlined in the "Work Areas and Specific Tasks" listed below and will train others in those areas. Level III Production Lab Techs will assume a leadership role in at least one Work Area and will be the go-to person for troubleshooting in area(s) of expertise. Level III Production Lab Techs performing Label and Documentation duties will perform all tasks in that area and will be proficient with Quality Systems or another Production-specific skill. Specific responsibilities include:

• Perform area clearance tasks and maintaining separation of product
• Perform standard and new operating procedures
• Collect and record data on documents and batch records where required
• Utilize computer hardware and software for data entry and record keeping where required
• Ensure compliance with all Quality and Regulatory specifications
• Support process improvement through identification and reporting of areas needing improvement and assisting in improvement projects
• Effectively utilize Quality Management Systems (QMS) and other applicable databases
• Familiarity with and proper use of safety equipment and Personal Protective Equipment (PPE)
• Demonstrate attention to detail and complete work according to daily schedule
• Verify data against standard
• Print and apply product labels based on established production plan
• Fill and package product based on an established production plan
• Fill and package product using standardized techniques and practices
• Stocks inventory as necessary
• Demonstrated ability to learn and understand safe laboratory practices
• Support 6S programs to maintain a Lean work environment
• Work occasional overtime and weekends as needed to meet production requirements
• Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations
• Report all deviations from established procedural documents to the appropriate supervisor/managers
• Additional duties as defined by management and business needs
• Participate in production failure investigations
• Attend and participate in scheduled meetings
• Compose emails to groups according to good business writing standards
• Effectively present DMS Board to management and coworkers
• Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual
• Other duties as assigned or required to support the business
• Customer service: Respond promptly to internal customer needs from other departments
• Professionalism: Approach others in a tactful manner, react well under pressure, treat others with respect and consideration, present a professional image in all business matters
• Productivity: Meet productivity standards, strive to increase productivity without sacrificing quality and safety
• Quality: Look for ways to improve and promote quality, demonstrate accuracy and thoroughness
• Continuous improvement: Regularly submit suggestions for improvement (SFls)
• Ethics: Treat people with respect, keep commitments, work with integrity and ethics, uphold organizational values
• Diversity: Promote a harassment-free environment, show respect and sensitivity for cultural differences
• Teamwork: Exhibit objectivity and openness to others' views, give and welcome feedback, supports others' efforts to succeed
• Problem solving: Identify and resolve problems in a timely manner, develop alternative solutions
• Safety: Observe safety procedures, report potentially unsafe conditions, use equipment and materials properly and according to usage guidelines
• Planning/organizing: Manage time and priorities work to meet deadlines, effectively multitask with various interruptions
• Judgment: Make timely decisions, exhibit sound and accurate judgment

Who You Are

Minimum Qualifications:

• High school diploma or GED required
• 2 years of within a production or manufacturing environment

Preferred Qualifications:

• 2 years of experience with general laboratory equipment
• Working knowledge of SAP, SAP NEXT, or other ERP systems
• Knowledge of GMP facility, FDA QSRs, and ISO 13485
• Experience in an FDA regulated biotechnology or pharmaceutical environment
• The ability to learn, understand, and carry out safe laboratory practices
• Proficiency with Quality Management Systems (QMS)
• Knowledge of the metric systems
• Ability to communicate effectively with all levels within the organization and with outside contacts

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html